Model Number ACU0T0 |
Device Problems
Failure to Deliver (2338); Defective Device (2588)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) procedure, the plunger went over the top of both lenses and the haptics did not open out correctly.The lenses came into contact with the patient.Additional information has been requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been requested and received stating the surgery was completed by exchanging the device.There was no patient impact.
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Search Alerts/Recalls
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